NEED FOR STANDARDS TO ENCOMPASS MULTIPLE RESEARCH SETTINGS AND METHODS

The accreditation process should accommodate other research organizationsin addition to the tradtional models provided by academic healthcenters and VA facilities. The accreditation process should alsocover research other than clinical research.

Standards must accommodate the distinct natures of several types of organizations, including research institutions, educational institutions, independent IRBs, academic medical centers, nongovernmental organizations, and private interests. A set of standards can make clear the scope of institutions to which they apply in several ways: (1) state explicitly in the preamble the intended focus of the standards; (2) include flexible language, such as “where applicable” or “as appropriate” to certain standards so that institutions not engaged in particular activities (e.g., nonmedical, low-risk research) could be exempt from certain standards (e.g., reporting of adverse events); or (3) organize the standards so that institutions and accreditation bodies can quickly ascertain which sections apply to them and which ones do not.

If standards were structured in a manner that requires the existence of a single entity with exclusive authority over all parties involved in the research process, then the three requirements listed above would not apply. It must be recognized, however, that certain organizations, such as independent IRBs and some private sponsors of research, would then not be eligible for accreditation. This would be an unfortunate consequence, as it would exclude organizations that play an increasing role in the research enterprise.

Accreditation of an independent IRB, for example, might use only the subset of standards pertinent to IRBs, but doing so would also require formal assurance regarding the functions covered by proposed standards that pertain to investigators, research institutions, and research participants, as well as standards that pertain to sponsors but that are not yet incorporated into NCQA or PRIM&R standards (but covered by ICH-GCP guidelines) (see discussion below). Another approach would be to accredit the organization that directly controls all the relevant elements of an HRPPP (e.g., a contract research organization that has a formal agreement with an independent IRB to review all its protocols, the research unit of a private firm, the unit of a federal agency that performs research, or a clinical trials cooperative group). One of the virtues of a nongovernmental voluntary accreditation process is its flexibility, and nongovernmental accreditation bodies should not find it difficult to accommodate disparate organizational structures. It is not yet clear, however, how the current proposed standards or accreditation processes would do so.

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